ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)

July 18, 2023 updated by: ASC Therapeutics

Evaluation of Safety and Efficacy of ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease

Acute GVHD following allogeneic HCT is an immune-triggered process, leading to profound immune dysregulation and organ dysfunction. Despite pivotal advances, aGVHD is one of the leading causes of non-relapse mortality in patients undergoing HCT.

Placenta-derived DSCs, isolated from the fetal membrane of maternal origin, are a type of stromal cells with well-characterized immunosuppressive properties. The current study is designed to assess the safety and efficacy of 4 intravenous (IV) doses of ASC930 DSC cells in aGVHD patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants ≥ 2 months of age
  • Diagnosis of aGVHD grade II-IV following allogeneic HSCT according to standard criteria (Harris, 2016).
  • Diagnosis of SR-aGVHD according to Mohty (2020)

  • Meet one of the following criteria:

    • Participants who are Ruxolitinib-refractory, according to Mohty (2020)
    • Participants who are not eligible for SOC therapy
    • Participants who agree to receive ASC930 as a second-line therapy
  • Karnofsky/Lansky Performance Status of at least 30 at the time of study entry
  • Minor participants must be capable of giving written assent as appropriate per the applicable age (per local regulatory requirements).

Exclusion Criteria:

  • Diagnosis of active Hepatic Sinusoidal Obstruction Syndrome (SOS)
  • Presence of an active uncontrolled infection
  • Active treatment for a hyprecoagulation disorder
  • Evidence of diffuse alveolar hemorrhage or other active pulmonary disease
  • Evidence of encephalopathy as defined by a change in mental status since the onset of aGVHD
  • Evidence of relapse of malignancy
  • Receival of agents other than steroids for primary treatment of aGVHD
  • Severe allergic history to cell-based products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ASC930
Experimental Arm
Biological: ASC930
4 intravenous doses of ASC930

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Response Rate (ORR) at Day 28
Time Frame: 28 days post-infusion
28 days post-infusion
Number of adverse events, and serious AEs
Time Frame: 30 days post-infusion
30 days post-infusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of response (DOR) at DAY 180
Time Frame: 180 days post-infusion
180 days post-infusion
Overall survival (OS) rate at DAY 180
Time Frame: 180 days post-infusion
180 days post-infusion
Complete Response (CR) at Day 28 and Day 180
Time Frame: 28 and 180 days post-infusion
28 and 180 days post-infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ASC Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

May 7, 2021

First Submitted That Met QC Criteria

May 7, 2021

First Posted (Actual)

May 12, 2021

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASC-aGVHD-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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